Paul White Paul.White@uwe.ac.uk
Professor in Applied Statistics
Rosemary Greenwood
Dr Praveen Kumar Praveen.Kumar@uwe.ac.uk
Associate Professor in Stroke Rehabilitation
Abstract
Background: A Lycra arm sleeve has the potential to reduce glenohumeral subluxation (GHS) in people with stroke (PwS). Aims were 1) to provide feasibility data to inform a future fully powered randomised controlled trial 2) to understand whether patients would be willing to be randomised 3) To measure changes in GHS at 3 months after wearing the sleeve when compared to not wearing the sleeve.
Method: PwS ≥18 years with ≤3/5 shoulder abduction strength and able to give informed consent were recruited. The feasibility data on recruitment, screening and retention rate at 12 weeks were collected. Participants were asked if they would be happy to be randomised into one of the two groups. The immediate group received the Lycra sleeve on recruitment and wore for up to 10hours/day for 3 months. The delayed group received the sleeve after follow-up assessment at 3 months. GHS was assessed using diagnostic ultrasound method.
Results: Over one year, 257 patients were screened, 34 patients were eligible and 31 (91%) were recruited. Retention at 3 months was 27 (87%. Of those eligible all found randomisation to be acceptable. In the immediate group, GHS showed reduction from 2.6±0.7cm (95% CI 2.0-3.1cm) at baseline to 2.2±0.4cm (CI 2.0-2.5cm) at 12 weeks. In the delayed group mean GHS remained unchanged over 3 months period (2.3±0.5cm, CI 1.9-2.7 cm).
Conclusion: Recruitment was harder than anticipated but there was high retention demonstrating feasible methodology. There is some indication of a clinical effect of Lycra sleeve on GHS early after stroke.
